US20110144665A1 - Surgical clip applier - Google Patents

Abstract

Surgical clip appliers are provided and include a housing; at least one handle pivotably connected to the housing; a channel assembly extending distally from the housing; a clip carrier disposed within the channel assembly and defining a channel and a plurality of windows therein; and a plurality of clips slidably disposed within the channel of the clip carrier. The surgical clip appliers further include a drive channel reciprocally disposed within at least one of the housing and the channel assembly; a wedge plate reciprocally disposed within the channel assembly; a pusher bar reciprocally positioned within the housing and the channel assembly; and a motion multiplier system having a plurality of linkage members configured to distally move the pusher bar by an incremental amount upon an initial actuation of the handles, and configured to proximally move the pusher bar and the wedge plate subsequent to the initial actuation of the handles.

Description

CROSS REFERENCE TO RELATED APPLICATION
• The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 61/286,569, filed on Dec. 15, 2009, the entire content of which is incorporate herein by reference.
BACKGROUND
• 1. Technical Field
• The present application relates to surgical instruments, and more particularly, to surgical clip appliers having a plurality of clips for applying the clips to body tissues and vessels during surgical procedures.
• 2. Discussion of Related Art
• Surgical clip appliers are known in the art and have increased in popularity among surgeons by offering an alternative to conventional suturing of body tissues and vessels. Typical instruments are disclosed in U.S. Pat. No. 5,030,226 to Green et al. and U.S. Pat. No. 5,431,668 to Burbank III et al. These instruments generally provide a plurality of clips which are stored in the instrument and which are fed sequentially to the jaw mechanism at the distal end of the instrument upon opening and closing of the handles at the proximal end of the instrument. As the handles are closed, the jaws close to deform a clip positioned between the jaw members, and as the jaws are opened to release the deformed clip, a new clip is fed from the series to a position between the jaws. This process is repeated until all the clips in the series of clips have been used.
• Surgical clip appliers are typically available in a variety of sizes and/or scales ranging from relatively small, relatively medium to relatively large. Generally, each particular size of surgical clip appliers includes different components. As such, the method of assembling the various sized surgical clip appliers differs from one size to another.
• As a consequence, each different size clip applier requires a different stroke length of external components (e.g., clip applier actuation) that, in turn, affects different timing of internal components (e.g., clip deployment components). The need therefore exists where certain essential components can be configured for each different sized clip applier by only changing geometry without changing functionality.
• In addition, the need therefore exists for a surgical clip applier that is configured to accommodate simple internal components that function in a similar fashion as all of the different sized clip appliers, with only changing the geometry of the components. At the same time not compromising a high clip pushing force with low driving force. Better motion and force characteristics and simpler components resulting in better performance of the device.
SUMMARY
• The present application relates to surgical clip appliers having a plurality of clips for applying the clips to body tissues and vessels during surgical.
• According to an aspect of the present disclosure, a surgical clip applier is provided including a housing; at least one handle pivotably connected to the housing; a channel assembly extending distally from the housing; a clip carrier disposed within the channel assembly and defining a channel and a plurality of windows therein; a plurality of clips slidably disposed within the channel of the clip carrier; a drive channel reciprocally disposed within at least one of the housing and the channel assembly, the drive channel having a first end operatively connected to the at least one handle and a second end operatively connected to a distal end of the channel assembly; a wedge plate reciprocally disposed within the channel assembly, the wedge plate being operatively connected to the at least one handle and including a plurality of apertures formed along a length thereof; a pusher bar reciprocally positioned within the housing and the channel assembly, the pusher bar having a proximal end operatively connected to at least one handle and a distal end defining a pusher, wherein the distal end of the pusher bar is configured for engagement with a distal-most clip of the plurality of clips; and a motion multiplier system having a plurality of linkage members configured to distally move the pusher bar by an incremental amount upon an initial actuation of the handles, and configured to proximally move the pusher bar and the wedge plate subsequent to the initial actuation of the handles.
• The plurality of linkages of the motion multiplier system may include a proximal linkage member pivotally supported in the housing and operatively connected to the drive channel; a pivoting drive arm interconnecting the drive channel and the proximal linkage member; and a distal linkage member interconnecting the proximal linkage member the pusher bar, such that a distal translation of the drive channel causes a pivotal rotation of the proximal linkage member via the pivoting drive arm, wherein the pivotal rotation of the proximal linkage member causes a pivotal rotation of the distal linkage member. The pivotal rotation of the distal linkage member causes a distal translation of the pusher bar. The proximal linkage member may be pivotally connected to the housing by a pivot pin. The distal linkage member may be pivotally connected to the proximal linkage member.
• A further distal translation of the drive channel may cause a further pivotal rotation of the proximal linkage member via the pivoting drive arm, wherein the further pivotal rotation of the proximal linkage member causes a further pivotal rotation of the distal linkage member, and wherein the further pivotal rotation of the distal linkage member causes a proximal translation of the pusher bar.
• In embodiments, when the proximal linkage member, the distal linkage member, the pivoting drive arm, the drive channel and the pusher bar are in a first position, the proximal linkage member and the distal linkage member define a first angle. Proximal translation of the drive channel causes the proximal linkage member and the distal linkage member, via the pivoting drive arm, to pivotally rotate thereby increasing the first angle to a second angle of about 180 degrees such that the proximal linkage member and the distal linkage member are linear to each other, such that the proximal linkage member, the distal linkage member, the pivoting drive arm, the drive channel and the pusher bar are in a second position.
• Further, when the proximal linkage member, the distal linkage member, the pivoting drive arm, the drive channel and the pusher bar are in the second position, further proximal translation of the drive channel causes the proximal linkage member and the distal linkage member, via the pivoting drive arm, to pivotally rotate thereby decreasing the second angle of about 180 degrees to a third angle, such that the distal linkage member, the pivoting drive arm, and the drive channel are in a third position, while the pusher bar is in the first position.
• The rotation of the proximal linkage member via the pivoting drive arm causes the proximal linkage member and the distal linkage member to be linear to each other and along a longitudinal axis defined by a reference axis between the proximal end of the proximal linkage member and the distal end of the distal linkage member, such that the distal linkage member causes a distal translation of the pusher bar.
• Further rotation of the proximal linkage member via the pivoting drive arm causes the proximal member and the distal linkage member to be angularly offset from each other, such that the distal linkage member causes a proximal translation of the pusher bar.
• A longitudinal axis, defined by a reference axis between the proximal end of the proximal linkage member and the distal end of the distal linkage member, and the proximal linkage member define a first acute angle on a first side of the longitudinal axis, and the pusher bar is in a proximal position. The distal translation of the drive channel may cause the proximal linkage member and the distal linkage member to pivot such that the first acute angle on the first side of the longitudinal axis increases until the proximal linkage member and the distal linkage member are linear to each other and the pusher bar has been distally translated via the distal linkage member to a distal position.
• Further distal translation of the drive channel causes the proximal linkage member and the distal linkage member to pivot from the side of the longitudinal axis to a second side of the longitudinal axis such that the proximal linkage member and the longitudinal axis define a second acute angle and the pusher bar has been proximally translated via the distal linkage member to a proximal position.
• The clip follower is configured to engage the wedge plate and move distally upon distal translation of the wedge plate, and is configured to engage the clip carrier and stop proximal movement thereof upon proximal translation of the wedge plate.
• The clip applier may further include a jaw assembly having a pair of jaws extending from an end of the channel assembly, opposite the housing. The jaw assembly may be adapted to accommodate a clip of the plurality of clips therein and is operable to effect formation of the clip in response to movement of the handles.
• The pusher bar may be movable towards the jaws as the handles are approximated in a first direction by an initial amount in order to move a distal-most clip between the jaws. The pusher bar may be configured and adapted to move towards the housing as the handles are approximated an additional amount in the first direction to move the pusher behind a distal-most clip in the plurality of clips.
• The drive channel may be configured and dimensioned to at least partially surround the jaws and the wedge plate. The drive channel may include a strap extending across a distal end thereof for maintaining the jaws and the wedge plate within the drive channel.
• The drive channel may be moved towards the jaw assembly as the at least one handle is moved actuated in a first direction to move the second end of the drive channel against the jaws to close the jaws, the drive channel being moved away from the jaws as the at least one handle is moved a second amount to move the second end of the drive channel away from the jaws to allow the jaws to open.
• In embodiments, the clip applier may further include a motion reversing mechanism operatively connected to the wedge plate and the drive channel. The rotation of the motion reversing mechanism, during distal movement of the drive channel, results in proximal movement of the wedge plate.
• In embodiments, the clip applier may further include a clip follower slidably disposed within the channel of the clip carrier and disposed proximally of the plurality of clips, the clip follower being configured and adapted for selective engagement with the windows of the clip carrier and the apertures of the wedge plate. The clip follower may be configured and adapted to urge the plurality of clips, in a distal direction relative to the clip carrier, upon reciprocal movement of the wedge plate.
• In embodiments, the clip applier may further include a motion reversing mechanism operatively connected to the drive channel and the wedge plate and selectively engageable with the pusher bar. The rotation of the motion reversing mechanism, during the distal translation of the drive channel, results in proximal movement of the wedge plate and the pusher bar.
• In embodiments, the clip applier may further include a ratchet mechanism. The ratchet mechanism may further include a rack, having a plurality of ratchet teeth, associated with the drive channel; and a pawl, having at least one tooth, disposed at a location to selectively engage the rack. The pawl may be biased into engagement with the rack, wherein as the drive channel is longitudinally reciprocated, the plurality of teeth are passed over the pawl. The pawl may prevent inadvertent return of the drive channel before full actuation of the at least one handle.
• In embodiments, the clip applier may further include a lockout disposed in a distal end of the channel assembly. The lockout may be actuated by the clip follower when a last clip is expelled from the clip applier. The lockout may be urged by the clip follower to extend across a path of the drive channel, thereby preventing the drive channel from moving distally.
• In embodiments, the clip applier may further include a counter display mechanism supported in at least one of the housing and the channel assembly. The counter display mechanism is configured and adapted to display a change in status of the clip applier upon each actuation of the at least one handle.
BRIEF DESCRIPTION OF THE DRAWINGS
• The present clip applier will be more fully appreciated as the same becomes better understood from the following detailed description when considered in connection with the following drawings, in which:
• FIG. 1 is a perspective view of a surgical clip applier according to an embodiment of the present disclosure;
• FIG. 1A is a rear, perspective view of the surgical clip applier ofFIG. 1, shown with a shipping wedge in position;
• FIG. 1B is a cross-sectional view as taken through1B-1B ofFIG. 1A;
• FIG. 1C is a cross-sectional view as taken through1C-1C ofFIG. 1A;
• FIG. 2 is a top, plan view of the surgical clip applier ofFIG. 1;
• FIG. 3 is a side, elevational view of the surgical clip applier ofFIGS. 1 and 2;
• FIG. 4 is an exploded perspective view of the surgical clip applier ofFIGS. 1-3;
• FIG. 4A is a perspective view of a motion multiplier system of the surgical clip applier ofFIGS. 1-4;
• FIG. 4B is an exploded perspective view of the motion multiplier system of the surgical clip applier ofFIGS. 1-4;
• FIG. 4C is a top, perspective view of a pivot arm of the surgical clip applier ofFIGS. 1-4;
• FIG. 4D is a bottom, perspective view of the pivot arm ofFIG. 4C;
• FIG. 4E is a top, perspective view of a clip follower of the surgical clip applier ofFIGS. 1-4;
• FIG. 4F is a perspective view of an audible/tactile indicator of the surgical clip applier ofFIGS. 1-4;
• FIG. 4G is a perspective view of a rack member of the surgical clip applier ofFIGS. 1-4;
• FIG. 4H is a top, perspective view of a surgical clip;
• FIG. 4I is a bottom, perspective view of the surgical clip ofFIG. 4H;
• FIG. 4J is a front, cross-sectional view of the surgical clip ofFIG. 4H, as taken through4J-4J ofFIG. 4H;
• FIG. 5 is a longitudinal cross-sectional view of the surgical clip applier ofFIGS. 1-4, illustrating the surgical clip applier in an unactuated condition;
• FIG. 6 is an enlarged view of the indicated area of detail ofFIG. 5;
• FIG. 7 is an enlarged view of the indicated area of detail ofFIG. 5;
• FIG. 8 is an enlarged view of the indicated area of detail ofFIG. 5;
• FIG. 9 is a cross-sectional view of the surgical clip applier ofFIGS. 1-4, as taken through9-9 ofFIG. 8;
• FIG. 10 is a perspective view of the surgical clip applier ofFIGS. 1-4, illustrated with an upper housing half removed therefrom;
• FIG. 11 is an enlarged view of the surgical clip applier ofFIGS. 1-4, as shown inFIG. 10;
• FIG. 12 is a top, perspective view of a distal end of a channel assembly of the surgical clip applier ofFIGS. 1-4, with a cover removed therefrom;
• FIG. 13 is a top, perspective view of the surgical clip applier ofFIGS. 1-4, illustrated with the upper housing half and a pusher bar removed therefrom;
• FIG. 14 is a top, perspective view of a distal end of the channel assembly ofFIG. 12, with the cover and the pusher bar removed therefrom;
• FIG. 15 is a top, perspective view of a distal end of the channel assembly ofFIG. 12, with the cover, the pusher bar and a clip carrier removed therefrom;
• FIG. 16 is a top, perspective view of a distal end of the channel assembly ofFIG. 12, with the cover, the pusher bar, the clip carrier, the surgical clips and the clip follower removed therefrom;
• FIG. 17 is an enlarged view of the indicated area of detail ofFIG. 16;
• FIG. 18 is a top, perspective view of the surgical clip applier ofFIGS. 1-4, illustrated with the upper housing half, the pusher bar and a wedge plate removed therefrom;
• FIG. 19 is a top, perspective view of a distal end of the channel assembly ofFIG. 12, with the cover, the pusher bar, the clip carrier, the surgical clips, the clip follower and the wedge plate removed therefrom;
• FIG. 20 is a top, perspective view of the surgical clip applier ofFIGS. 1-4, illustrated with the upper housing half, the pusher bar, the wedge plate and a drive channel removed therefrom;
• FIG. 21 is a bottom, perspective view of the surgical clip applier ofFIGS. 1-4, illustrated with a lower housing half, the drive channel and the wedge plate removed therefrom;
• FIG. 22 is a top, plan view of the surgical clip applier ofFIGS. 1-4, with the upper housing half removed therefrom and shown in an un-actuated condition;
• FIG. 23 is an enlarged view of the indicated area of detail ofFIG. 22;
• FIG. 24 is an enlarged view of the indicated area of detail ofFIG. 22;
• FIG. 24A is a schematic illustration of the motion multiplier system ofFIG. 24;
• FIG. 25 is a top, plan view of the surgical clip applier ofFIGS. 1-4, with the upper housing half removed therefrom and shown during an initial actuation thereof;
• FIG. 26 is an enlarged view of the indicated area of detail ofFIG. 25;
• FIG. 27 is an enlarged view of the indicated area of detail ofFIG. 25;
• FIG. 27A is a schematic illustration of the motion multiplier system ofFIG. 27;
• FIG. 28 is an enlarged, longitudinal cross-sectional view of the distal end of the channel assembly during the initial actuation of the surgical clip applier;
• FIG. 29 is a top, perspective view of the surgical clip applier ofFIGS. 1-4, illustrated with the upper housing half and a pusher bar removed therefrom and shown in during an initial actuation thereof;
• FIG. 30 is an enlarged, longitudinal cross-sectional view of the distal end of the channel assembly during a further initial actuation of the surgical clip applier;
• FIG. 31 is bottom, perspective view illustrating the operation of an audible/tactile indicator during the respective initial actuation of the surgical clip applier ofFIGS. 1-4;
• FIG. 32 is a top, plan view of the surgical clip applier ofFIGS. 1-4, with the upper housing half removed therefrom and shown during a further actuation of the surgical clip applier;
• FIG. 33 is an enlarged view of the indicated area of detail ofFIG. 32;
• FIG. 34 is an enlarged, cross-sectional view illustrating an actuation of a counter mechanism of the surgical clip applier ofFIGS. 1-4;
• FIG. 35 is an enlarged view of the indicated area of detail ofFIG. 32;
• FIG. 36 is an enlarged view of a ratchet mechanism shown during the final actuation of the surgical clip applier ofFIGS. 1-4;
• FIGS. 37 and 38 are enlarged perspective view, illustrating the distal end of the channel assembly during the final actuation of the surgical clip applier ofFIGS. 1-4;
• FIG. 39 is a top, plan view of the surgical clip applier ofFIGS. 1-4, with the upper housing half removed therefrom and shown at a final condition after an actuation of the surgical clip applier;
• FIG. 40 is an enlarged view of the indicated area of detail ofFIG. 39;
• FIG. 41 is an enlarged view of the indicated area of detail ofFIG. 39;
• FIG. 41A is a schematic illustration of the motion multiplier system ofFIG. 41;
• FIG. 42 is an enlarged view illustrating the position of the audible/tactile indicator following an actuation of the surgical clip applier ofFIGS. 1-4;
• FIG. 43 is a top, plan view of the jaw assembly illustrating the position of the jaw assembly following an actuation of the surgical clip applier ofFIGS. 1-4;
• FIG. 44 is a perspective view of a body vessel including a clip of the surgical clip applier, shown applied thereto;
• FIG. 45 is an enlarged view of the indicated areas of detail ofFIGS. 22,25,32, and39, illustrating the operation of the pivot aim during an opening or release of the surgical clip applier following a complete actuation thereof;
• FIG. 46 is an enlarged view of the ratchet mechanism shown during the opening or release of the surgical clip applier ofFIGS. 1-4;
• FIG. 47 is an enlarged view illustrating the operation of the audible/tactile indicator during the opening or release of the surgical clip applier ofFIGS. 1-4;
• FIGS. 48 and 49 are longitudinal, cross-sectional views of the channel assembly illustrating the movement of the clip follower during the opening or release of the surgical clip applier ofFIGS. 1-4;
• FIGS. 50 and 51 are longitudinal, cross-sectional views of the distal end of the channel assembly illustrating the movement of the pusher bar and wedge plate during the opening or release of the surgical clip applier ofFIGS. 1-4; and
• FIG. 52 is a longitudinal, cross-sectional view of the distal end of the channel assembly illustrating the surgical clip applier ofFIGS. 1-4 in a locked-out condition following firing of the last surgical clip therefrom.
DETAILED DESCRIPTION OF EMBODIMENTS
• Embodiments of surgical clip appliers in accordance with the present disclosure will now be described in detail with reference to the drawing figures wherein like reference numerals identify similar or identical structural elements. As shown in the drawings and described throughout the following description, as is traditional when referring to relative positioning on a surgical instrument, the term “proximal” refers to the end of the apparatus which is closer to the user and the term “distal” refers to the end of the apparatus which is further away from the user.
• FIGS. 1-5 illustrate a surgical clip applier in accordance with an embodiment of the present disclosure and is generally designated as100. Reference may be made to U.S. Provisional Application No. 61/091,467, filed on Aug. 25, 2008, entitled “Surgical Clip Applier” and U.S. Provisional Application No. 61/091,485, filed on Aug. 25, 2008, entitled “Surgical Clip Applier and Method of Assembly,” the entire contents of each of which being incorporated herein by reference, for a detailed discussion of the structure, operation, and method of assembly ofsurgical clip applier100.
• Surgical clip applier100 is a surgical instrument including ahandle assembly102 including ahousing104 having anupper housing half104aandlower housing half104b.Handle assembly102 further includes a pair ofhandles106 pivotably secured tohousing104 and extending outwardly therefrom. Achannel assembly108 is fixedly secured tohousing104 and extends outwardly therefrom, terminating in ajaw assembly110.
• As seen inFIGS. 1-4,housing halves104aand104bofclip applier100 fit together by snap fit engagement with one another.Housing104 defines awindow104cformed inlower housing half104bfor supporting and displaying a counter mechanism, as will be discussed in greater detail below.Housing104 is formed of a suitable plastic material.
• As seen inFIG. 4, handles106 are secured tohousing104 byhandle pivot posts104dextending fromlower housing half104band intorespective apertures106aformed inhandles106.Handle assembly102 includes alink member122 pivotally connected to each handle106 at apivot point106bformed in arespective handle106. Adistal end122aof eachlink member122 is pivotally connected to apivot point140aformed in adrive channel140 via adrive pin124. Each end ofdrive pin124 is slidably received in anelongate channel104eformed in a respective upper andlower housing half104a,104b.In use, as will be described in greater detail below, ashandles106 are squeezed, linkmembers122push drive channel140 distally viadrive pin124.
• Channel assembly108 includes a channel orcartridge cover130 and an outer orlower channel132 each having a proximal end retained inhousing assembly102, between upper andlower housing halves104a,104b.Cartridge cover130 includes at least oneretention element130aconfigured and adapted to selectively engage, in a snap-fit engagement, a complementary orcorresponding retention element132aprovided onouter channel132.
• As seen in FIGS.4 and6-12,clip applier100 includes aclip pusher bar160 slidably disposed beneathcartridge cover130.Pusher bar160 includes adistal end160adefining apusher160cconfigured and adapted to selectively engage/move a distal-most clip “C1” stored insurgical clip applier100.Pusher bar160 further includes aproximal end160bdefining a firstproximal window160dand a secondproximal window160htherein. Firstproximal window160dis configured for slidably receivingdrive pin124 therein and secondproximal window160his configured for slidably receiving fixedrod154atherein.Pusher bar160 further defines adistal window160eand aproximal window160gtherein for operative engagement with astabilizer162, as will be discussed in greater detail below.Pusher bar160 further includes anaperture160fconfigured to receive a slidingpost158cof adistal linkage member158, as will described in greater detail below.
• Clip applier100 further includes astabilizer162 configured to overlie and engagepusher bar160.Stabilizer162 includes adistal tab162aconfigured to engagedistal window160eofpusher bar160,elongate windows162band162ddefined therein at a location to substantially overlie and be in registration with respectiveproximal windows160dand160hformed inpusher bar160. As seen inFIGS. 4 and 6,stabilizer162 further includes a plurality oftabs162eextending from a top surface thereof, at a proximal and a distal location, which are configured and dimensioned for receipt in respective channels formed inupper housing half104a.Stabilizer162 further includes anaperture162fthat overliesaperture160fofpusher bar160.Apertures160fand162fare both configured to receive slidingpost158cofdistal linkage member158.
• As seen inFIGS. 4,4A,4B, and24,clip applier100 further includes amotion multiplier system155 in the form of a three-bar linkage system having aproximal linkage member154 that is pivotally supported inhousing104 and operatively connected to drivechannel140 via a pivotingdrive arm156. Pivotingdrive arm156 is pivotably coupled by apin156aviaaperture156btohousing104.Motion multiplier system155 further includes adistal linkage member158 that interconnectsproximal linkage member154 andpusher bar160. A longitudinal axis “X1” is defined along an axis extending through fixedrod154aofproximal linkage member154 and slidingpost158cofdistal linkage member158. A side of longitudinal axis “X1,” that includes pivotingdrive arm156, defines a first side and the other side of longitudinal axis “X1” defines a second side. On the first side,proximal linkage member154 is pivotally oriented at an angle “α” relative to longitudinal axis “X1” (as shown inFIG. 24). On the second side,proximal linkage member154 is pivotally oriented at an angle “−α” relative to longitudinal axis “X1” (as shown inFIG. 35). In essence, whenproximal linkage member154 is oriented between angle “α” and angle “−α,” the angle is 0°, such thatproximal linkage member154 is aligned with longitudinal axis “X1” (as shown inFIG. 27). In this configuration,proximal linkage member154 is also aligned withdistal linkage member158, as will be discussed in greater detail below. Pivotingdrive arm156 is pivotally supported via apivot pin156asecured and driven bydrive channel140. A longitudinal axis “X2” is defined along an axis extending alongdrive channel140. In this manner, pivotingdrive arm156 is pivotally oriented at an angle “β” relative to longitudinal axis “X2” (as shown inFIG. 24).
• Proximal linkage member154 includes ahub154bthat is configured to receive a fixedrod154atherethrough, such that a pivotable connection betweenproximal linkage member154 andhousing104 is established.Proximal linkage member154 also includes aproximal aperture154cand adistal aperture154d.Proximal aperture154cis configured to receive a drivingpost156cof pivotingdrive arm156 that selectively drivesproximal linkage member154 in a rotational manner, as will be discussed in greater detail below.Distal aperture154dis configured to receive acoupling pin158aviaaperture158bofdistal linkage member158 that pivotally couplesproximal linkage member154 todistal linkage member158.Distal linkage member158 further includes apost158cthat is slidably connected toaperture160fofpusher bar160 andaperture162fofstabilizer162.Distal linkage member158 via slidingpost158ceffectuates translation ofpusher bar160 andstabilizer162 in a proximal and distal direction.
• Clip applier100 further includes aclip carrier170 disposed withinchannel assembly108 and beneathpusher bar160.Clip carrier170 is generally a box-like structure having anupper wall170a,a pair ofside walls170band alower wall170cdefining achannel170dtherethrough.Clip carrier170 includes a plurality of spaced apartwindows172 formed inupper wall170aand extending longitudinally along a length thereof.Clip carrier170 includes anelongate window170e(as shown inFIG. 9) formed inlower wall170cand extending longitudinally along a length thereof.
• As seen inFIGS. 4H-4J, a surgical clip “C” includes a first leg “C2' and a second leg “C4.” Each of legs “C2” and “C4” of surgical clip “C” are connected to one another to form an apex “C14.” Apex “C14” of surgical clip “C” has a generally V-shaped configuration as shown inFIGS. 4H-4I. First leg “C2” of surgical clip “C” further includes a gripping pattern “C6” on an interior wall that defines a plurality of recesses “C8.” Second leg “C4” of surgical clip “C” includes a plurality of indentations “C10” on an exterior wall and a plurality of protrusions “C12” on an interior wall. When surgical clip “C” is applied to tissue, as the application a clip “C” to tissue will be described in greater detail below, legs “C2” and “C4” come together, such that plurality of indentations “C10” and plurality of protrusions “C12” grip and hold a tissue therebetween. For a more detailed discussion of surgical clip “C,” please refer to commonly owned U.S. Publication No. 2007/0173866, filed on Jan. 23, 2006, entitled “Surgical Hemostatic Clip,” the entire contents of which is incorporated herein by reference in its entirety.
• As seen inFIGS. 4,9 and14, a stack of surgical clips “C” is loaded and/or retained withinchannel170dofclip carrier170 in a manner so as to slide therewithin and/or therealong.Channel170dis configured and dimensioned to slidably retain a stack or plurality of surgical clips “C” in tip-to-tail fashion therewithin.
• As seen inFIGS. 12 and 14, a distal end ofclip carrier170 includes a pair of spaced apart,resilient tangs171.Tangs171 are configured and adapted to selectively engage a backspan of a distal-most surgical clip “C1” of the stack of surgical clips “C” retained withincarrier170.
• As seen inFIGS. 4,4E,7 and15,clip applier100 further includes aclip follower174 slidably disposed withinchannel170dofclip carrier170. As will be discussed in greater detail below,clip follower174 is positioned behind the stack of surgical clips “C” and is provided to urge the stack of clips “C” forward during an actuation ofclip applier100. As will be described in greater detail below,clip follower174 is actuated by the reciprocating forward and backward motion ofwedge plate180.
• As seen inFIGS. 4E and 7,clip follower174 includesbody portion174adefining a plane, adistal tab175 extending substantially upwardly and rearwardly frombody portion174a,and aproximal tab176 extending substantially downwardly and rearwardly frombody portion174a.Distal tab175 includes adistal portion175aextending downwardly below the plane defined bybody portion174aand aproximal portion175bextending upwardly above the plane defined bybody portion174a.
• Proximal portion175bofdistal tab175 is configured and dimensioned to selectively engagewindows172 formed inupper wall170aofclip carrier170. In use, engagement ofproximal portion175bofdistal tab175 ofclip follower174 in awindow172 formed inupper wall170aofclip carrier170 prevents clip follower from traveling or moving in a proximal direction.
• Proximal tab176 is configured and dimensioned to selectively engagewindows180bformed inwedge plate180. In use, engagement ofproximal tab176 ofclip follower174 in awindow180bformed inwedge plate180 allows forclip follower174 to be advanced or moved distally upon a distal movement ofwedge plate180.
• As seen inFIGS. 4,7-9,16 and17,clip applier100 further includes awedge plate180 slidably disposed withinhandle assembly102 andchannel assembly108.Wedge plate180 is positioned or disposed belowclip carrier170.Wedge plate180 includes a substantially tapereddistal end180afor selective operative interposition betweenjaws120.Wedge plate180 defines a plurality of spaced apart windows orapertures180bextending longitudinally along a length thereof and formed in a raised section thereof, a distal window oraperture180clocated distal ofapertures180b,and a proximal-most transversely orientedslot180dlocated proximal ofaperture180c.
• As seen inFIGS. 4,8,16 and17,clip applier100 includes adistal lockout178 supported bycartridge cover130.Distal lockout178 includes a tail ortab178aextending substantially rearwardly and downwardly and being configured and dimensioned for receipt in distal window oraperture180cofwedge plate180.
• As seen inFIGS. 4,4C,4D,6,11,13,18 and20,clip applier100 includes a wedge plate motion reversing mechanism, in the form of apivot arm179, pivotally supported inlower housing half104bofhousing104 for transmitting the translation ofdrive channel140 to a reverse translation ofwedge plate180.Pivot arm179 includes apivot boss179aconfigured for pivotable connection tohousing104, a first stem orfinger179bprovided at one end ofpivot arm179 and extending in a direction opposite to pivotboss179a,and second stem orfinger179cprovided at a second end ofpivot arm179 and extending in a direction alongside first stem orfinger179bandpivot boss179a.First stem orfinger179bis configured and adapted for engagement inproximal-most slot180dofwedge plate180. Second stem orfinger179cis configured for engagement in aslot140gformed indrive channel140 which is connected in awindow140gdefined in adrive channel140. Slot140gincludes a longitudinally extending distal portion and a longitudinally extending proximal portion that are axially and transversely offset from one another, and a transverse portion interconnecting the distal and proximal portions.
• In use, as will be discussed in greater detail below, asdrive channel140 is moved distally, after a dwell period (i.e., the length of the longitudinally extending distal portion ofslot140gof drive channel140), second stem orfinger179cis moved in a distal direction, rotatingpivot arm179 and thereby moving first stem orfinger179bin a second direction. As first stem orfinger179bis moved in the second direction, first stem orfinger179bpullswedge plate180 out from betweenjaws120 urges against. Aswedge plate180 is moved in a distal direction, as seen nFIG. 17,distal end180aofwedge plate180 cams against an inner surface ofjaws120 to thereby maintainjaws120 spaced apart from one another.
• As seen inFIGS. 4,6-11,13,18 and19,clip applier100 includes adrive channel140 reciprocally supported in and extending betweenhousing104 ofhandle assembly102 andchannel assembly108. A proximal end ofdrive channel140 is supported between upper andlower housing halves104a,104bofhousing104 and a distal end ofdrive channel140 is supported betweencartridge cover130 andouter channel132 ofchannel assembly108, at a location belowwedge plate180.
• A distal end ofdrive channel140 is a substantially U-shaped channel including a pair of spaced apartside walls140bextending from abackspan140cthereof, in a direction away fromouter channel132 and towardcartridge cover130.Drive channel140 further defines adrive pin recess140aformed inbackspan140cfor pivotally receivingdrive pin124 therethrough.Drive channel140 further defines arib140eprojecting frombackspan140cat a location distal ofdrive pin recess140a.Drive channel140 further defines areciprocation limiting slot140fformed inbackspan140cat a location distal ofslot140e.
• As seen inFIGS. 4,8,9,12,14-16 and19,clip applier100 includes adrive channel strap143 secured to drivechannel140.Strap143 is secured touprights140bofdrive channel140 so as to extend transversely thereacross.Strap143 is secured to drivechannel140 at a location distal ofreciprocation limiting slot140f.Strap143 is secured to drivechannel140 such thatwedge plate180 extends beneathstrap143 and abovejaws120.
• As seen inFIGS. 4,4F,6,10 and21,clip applier100 further includes an audible/tactile indicator148 connected to drivechannel140 viadrive pin124.Indicator148 includes aresilient finger148aand a pair ofbosses148b.In use, as will be described in greater detail below, asclip applier100 is actuated and drivechannel140 is reciprocated, firstresilient finger148aofindicator148 interacts with corresponding complementary structure orledge149 provided inclip applier100 to create an audible and/or a tactile feedback to the user.Bosses148bofindicator148 ride withinchannel104eformed inupper housing half104aand provide support toindicator148 to preventindicator148 from rotating.
• As seen inFIGS. 4,6,10,11,13,18 and20,clip applier100 further includes a biasingmember146, in the form of a tension spring, operatively secured to and between a proximal end ofdrive channel140 andhousing104, tending to maintaindrive channel140 in a retracted or proximal-most position.Biasing member146 functions to retract or facilitate retraction ofdrive channel140 following formation of a clip “C” positioned betweenjaws120.
• As seen inFIGS. 4,4G,11,13,18 and20, a proximal end ofdrive channel140 includes aratchet rack member141 secured to drivepin124 and movable withdrive channel140.Ratchet member141 includes aslot141bto slidably receive fixedrod154a.Ratchet member141 further includes atab141cextending from a proximal end thereof that slidably translates withinlower housing half104b.Ratchet rack member141 is configured and adapted to engage with aratchet pawl142 supported inhousing104.Rack member141 and ratchetpawl142 define aratchet mechanism144. In use, asdrive channel140 is moved axially,rack member141 is also moved.Rack member141 defines a series ofrack teeth141ahaving a length which allowspawl142 to reverse and advance back overrack member141 whenrack member141 changes between proximal and distal movement asdrive channel140 reaches a proximal-most or distal-most position.
• Pawl142 is pivotally connected to lowerhousing half104bby apawl pin147 at a location whereinpawl142 is in substantial operative engagement withrack member141.Pawl142 is engageable withrack member141 to restrict longitudinal movement ofrack member141 and, in turn,drive channel140.Ratchet mechanism144 further includes apawl spring145 configured and positioned to biaspawl142 into operative engagement withrack member141.Pawl spring145 functions to maintain the teeth ofpawl142 in engagement with theteeth141aofrack member141, as well as to maintainpawl142 in a rotated or canted position.
• As seen inFIGS. 1-4,8,10,12,14-17 and19,clip applier100 includes a pair ofjaws120 mounted on or at a distal end ofchannel assembly108 and actuatable byhandles106 ofhandle assembly102.Jaws120 are formed of a suitable biocompatible material such as, for example, stainless steel or titanium.
• Jaws120 are mounted in a distal end ofdrive channel140 via one ormore rivets120cor the like extending throughreciprocation limiting slot140fofdrive channel140 such thatjaws120 are longitudinally stationary relative toouter channel132 and drivechannel140. As seen inFIGS. 12,14,17 and19,jaws120 define achannel120atherebetween for receipt of a surgical clip “C1” therein.
• As seen inFIGS. 1-4,6,11,13 and20,clip applier100 further includes acounter mechanism190 supported inhousing104 ofhandle assembly102.Counter mechanism190 includes adisplay192, aprocessor194, and anenergy source198 in the form of a battery or the like.Display192 is a liquid crystal display that displays one or more operating parameters ofclip applier100 to the surgeon. The operating parameter displayed may be an amount or number of remaining clips, a number of clips that have been used, a position parameter, a surgical time of usage, or any other parameter of the procedure.
• Counter mechanism190 includes atab192a,made from PVC, disposed between battery orenergy source198 and acontact194aofprocessor194 or between thecontacts194aofprocessor194 to prevent the battery orenergy source198 from becoming drained during storage. As seen inFIGS. 1A and 1B,tab192aextends out ofhousing104 ofclip applier100 in order to allow for easy removal of the tab therefrom. Once thetab192ais removed, battery orenergy source198 comes into electrical contact with thecontact194aofprocessor194 or between thecontacts194aof theprocessor194.
• Counter mechanism190 is actuated bynub140eformed indrive channel140. In use, as seen inFIG. 36, asdrive channel140 is driven forward, nub140ethereof engages contact194acausingcontact194ato complete a circuit andtrigger processor194 to perform a function (e.g., reduce the number appearing ondisplay192 by a give increment or value).
• As seen inFIGS. 1A and 1C,clip applier100 includes ashipping wedge200 supported onhousing104 and interposed betweenhandles106.Shipping wedge200 functions to maintainhandles106 spaced apart or un-squeezed during a shipment and/or storage ofclip applier100.Shipping wedge200 is connected totab192aofcounter mechanism190, such that in order for an end user to useclip applier100, the end user must removeshipping wedge200 thereby also removingtab192ato activatecounter mechanism190.
• As seen inFIGS. 1A and 1C,shipping wedge200 includes abody portion202 in the form of a collar, defining apassage204 configured and dimensioned for receipt of a portion ofhousing104 therein.Shipping wedge200 includesuprights206 extending outwardly from opposed sides ofbody portion202 and being configured to receivehandles106 therein.Shipping wedge200 further includestabs208 extending inwardly from opposed sides ofuprights206.Tabs208 ofshipping wedge200 are configured and dimensioned to engage withhandles106 when shippingwedge200 is properly secured to clipapplier100.
• With reference toFIGS. 22-53, the operation ofclip applier100 is provided. Prior to any initial squeezing ofhandles106 ofclip applier100, as seen inFIGS. 22-24, the internal components of theclip applier100 are in a so-called “home” position or “starting” position. More particularly, in the “home” position, thedrive pin124 is located at a proximal-most position,pawl142 is located distal of rack140dofdrive channel140,second finger179cofpivot arm179 is located at a distal-most position in the distal portion ofwindow140gofdrive channel140 such thatwedge plate180 is located at a distal-most position, and no clips “C” are positioned withinjaws120. Sincedrive pin124 is at a proximal-most position,pusher bar160,stabilizer162, and drivechannel140 are also at a proximal-most position.
• As seen inFIG. 24, whendrive channel140 andpusher bar160 are located at the proximal-most position, drivingpost156cof pivotingdrive arm156 is located at a proximal-most position and secondresilient finger148bofindicator148 is disposed proximal ofedge149 formed inlower housing half104b.In embodiments,edge149 may be formed inupper housing half104awith slight modification toindicator148. In the “home” position, angle “α” ofproximal linkage member154 may range from about 45° to about 60°, while angle “β” of pivotingdrive arm156 may range from about 20° to about 25°. Also, prior to an initial squeezing ofhandles106 ofclip applier100, withwedge plate180 located at a distal-most position,distal end180athereof is interposed betweenjaws120.
• As seen inFIGS. 22,24 and24A, also in the “home”position coupling pin158aofdistal linkage member158 is located on a first side of the longitudinal axis “X1.”
• The following equations are used to calculate the mechanics of themotion multiplier system155 in a “home” position. The “home” position directly relates to whenpusher bar160 is in the “home” position (i.e., proximal-most position), for example, when “α” is about 60°.
• 
  XP=(2)(L1)(cos α)−(L1)   (1)
• where distance “XP” is the distance traveled by slidingpost158cand length “L1” is the length of proximal anddistal linkage members154 and156, as shown inFIG. 24A.
• 
  XD=(B)+(C)(cos α)−(L2)(cos β)   (2)
• where distance “XD” is the distance traveled bypivot post156aof pivotingdrive arm156 along longitudinal axis “X2,” distance “B” is distance betweenpivot pin156aof pivotingdrive arm156 and fixedrod154aofproximal linkage member154 taken along the longitudinal axis of “X1,” distance “C” is the distance between fixedrod154aofproximal linkage member154 and drivingpost156cof pivotingdrive aim156, and length “L2” is the length of pivotingdrive arm156 taken frompivot post156ato drivingpost156c,as shown inFIG. 24A.
• Also prior to the initial squeeze, there are no clips “C” present withinjaws120. A clip “C” is first loaded intojaws120 during the initial squeezing ofhandles106. As seen inFIGS. 25-33, during an initial squeeze of handles106 (i.e., a working stroke), distal ends122aoflink members122 are moved distally relative tohousing104. As distal ends122aoflink members122 are moved distally,drive pin124 is moved distally thereby transmitting distal axial movement to drivechannel140.
• Subsequently, as seen inFIGS. 25-31, asdrive channel140 is moved distally,motion multiplier system155 moves from the “home” position to an initial actuated position. More particularly,drive channel140 advances in a distal direction, which, in turn, causes pivotingdrive arm156 to move in a distal direction. That is, pivotingdrive arm156 pivots and drivesproximal linkage member154 to rotate in a direction such that angle “β” increases, for example, but not limited from about 22° to about 45°. In this manner, when angle “β” is increased,proximal linkage member154 is rotated about fixedrod154aofproximal linkage member154, which, in turn, causes drivingpost158cofdistal linkage member158 to be driven distally alongslot162bofstabilizer162 andproximal window160dofpusher bar160. As drivingpost158cofdistal linkage member158 is driven distally, drivingpost158cofdistal linkage member158 drives pusher bar160 in a distal direction.
• As seen inFIGS. 25,32 and33, during the initial squeeze ofhandles106,indicator148 is moved distally along with the distal movement ofdrive channel140. In use,indicator148 functions to create an audible click and/or a tactile vibration, thereby indicating to the user that handles106 ofsurgical clip applier100 have gone through at least a portion of a stroke. In particular, as seen inFIGS. 32 and 33, ashandles106 are actuated, firstresilient arm148aof audible/tactile indicator148 rides over and/or along aledge149 formed in at least one of upper andlower housing halves104a,104band is flexed thereby. Asarm148aof audible/tactile indicator148 reaches the proximal end ofledge149,resilient arm148asnaps over the proximal end ofledge149 and comes into contact with a surface149aofledge149, thereby creating a first audible sound and a tactile vibration asresilient arm148acomes into contact with surface149aofledge149. The first indication of audible/tactile indicator148 indicates to the user that a clip “C” has been appropriately loaded.
• As seen inFIGS. 28 and 30, also during the initial squeeze ofhandles106, aspusher bar160 is moved in a distal direction,pusher160cthereof engages a backspan of a distal-most clip “C1” and begins to move or urge distal-most clip “C1” distally out ofclip carrier170 and intojaws120. As distal-most clip “C1” is moved distally,tangs171 ofclip carrier170 are deflected or cammed out of engagement with distal-most clip “C1” and return to their un-deflected or un-cammed state to capture a subsequent clip of the stack of clips “C”. During the initial squeeze ofhandles106,pusher bar160 is advanced an amount sufficient to place distal-most clip “C1” inchannels120aofjaws120.
• As seen inFIGS. 27 and 31, also during the initial squeeze ofhandles106, asdrive channel140 is moved in a distal direction,rack member141 ofratchet mechanism144 is moved distally causingteeth141athereof to move into engagement with and over or across a tooth ofpawl142. Oncerack member141 ofratchet mechanism144 is moved into engagement withpawl142,drive channel140 can not return to a home or proximal-most position untilrack member141 has clearedpawl142.
• During the initial squeeze ofhandles106, as seen inFIGS. 25-33,drive channel140 is moved distally untilfinger179cofpivot arm179 is engaged by the transverse portion ofslot140gof drive channel140 (i.e., the dwell). Once the transverse portion ofslot140gis in abutment withfinger179cof pivot arm179 (i.e., after the dwell has been exhausted), further distal movement ofdrive channel140 causesfinger179cto move and rotatepivot arm179. Rotation ofpivot arm179 causes movement offinger179bthereof which, in turn, causeswedge plate180 to be pulled in a proximal direction, thereby withdrawingdistal end180athereof from betweenjaws120 and allowing forjaws120 to eventually be closed or approximated thus allowing forjaws120 to eventually be closed or approximated.
• Once the required rotation ofpivot arm179 is achieved,pivot arm179 stops rotating asfinger179cofpivot arm179 rides through the proximal portion ofslot140gofdrive channel140.Finger179cofpivot arm179 remains in the proximal portion ofslot140gofdrive channel140 until the stroke ofdrive channel140 is completed.
• As seen inFIGS. 25-31, during a further squeeze ofhandles106,pusher bar160 is moved distally withdrive channel140, as described above, until pivotingdrive arm156 has reached a position, such that angle “β” is 45°. In this configuration, proximal anddistal linkage members154 and158 are aligned along longitudinal axis “X1” such that angle “a” therebetween is about 0°.
• The following equation is used to calculate the mechanics of themotion multiplier system155 when in a “fully extended” position. The “fully extended” position directly relates to whenpusher bar160 is in a “fully extended” position (i.e., distal-most position), for example, when angle “α” is about 0°.
• 
  XE=(B)+(C)−(L2)(cos β₀)   (3)
• where distance “XE” is the distance between the “home” position ofpivot pin156aof pivotingdrive arm156 and the “fully extended” position ofpivot pin156aof pivotingdrive arm156 taken along longitudinal axis “X2” ofdrive channel140, distance “B” is the distance betweenpivot pin156aof pivotingdrive arm156 and fixedrod154aofproximal linkage member154 taken along longitudinal axis “X1”, distance “C” is the distance betweencoupling pin158cofdistal linkage member158 and drivingpost156cof pivotingdrive arm156, length “L2” is the length of pivotingdrive arm156 taken frompivot post156ato drivingpost156c,and angle “β₀” is the “fully extended” position angle of angle “β” when angle “α” is about 0°. In this case, angle “β₀” of pivotingdrive arm156 is about 45°, as described above and shown inFIG. 27A.
• As seen inFIG. 31, asdrive channel140 is further advanced distally,drive channel140 pulls or flexesresilient finger148aofindicator148 over a proximal end ofledge149. In this manner, a first indication (i.e., audible and/or tactile) is created indicating to a user that a surgical clip “C” has been appropriately loaded.
• As seen inFIGS. 25 and 27, also in the “fully extended” position, proximal anddistal linkage member154 and158 are aligned and/or parallel with longitudinal axis “X1.”
• Referring now toFIGS. 32-35, during a further squeezing ofhandles106, distal ends122aoflink members122 are caused to be moved further distally relative tohousing104. As distal ends122aoflink members122 are moved further distally,drive pin124 is caused to be moved further distally thereby transmitting distal axial movement to drivechannel140.
• As seen inFIGS. 32,33, and35, ashandles106 are continuously squeezed, pivotingdrive arm156 continues to move in a distal direction such that angle “β”, between pivotingdrive arm156 and longitudinal axis “X2” ofdrive channel140, continuously increases asdrive channel140 moves in the distal direction to about 90°. This movement also causes proximal linkage member154 (i.e., positioned on the first side) to pivot or move over-center to the second side, with reference to longitudinal axis “X1”, such that angle betweenproximal linkage member154 is pivotally oriented at an angle “−α” relative to longitudinal axis “X1” (as shown inFIG. 35). In this manner, asproximal linkage member154 rotates about longitudinal axis “X1,” angle “−α” decreases from about 0° to about 60° causingdistal linkage member158 to move in a proximal direction. In this configuration, slidingpost158cofdistal linkage member158 slides in a proximal direction, which, in turn, slidespusher bar160 andstabilizer162 back to a retracted position or a “safe” position. In the “safe” position, other components ofclip applier100, such asdrive bar140, are still moving in a distal direction so that clip “C” may be formed betweenjaw members120. However, in the “safe” position,pusher bar160 is safely retracted to a proximal position such thatpusher bar160 does not interfere withclip applier100 whenjaw members120 are approximated towards one another.
• The following equation is used to calculate the mechanics of themotion multiplier system155 when in a “safe” position. The “safe” position, as discussed above, directly relates to whenpusher bar160 is in a safe retracted position (i.e., proximal-most position), while other components ofclip applier100, for example, handles106 are still in a working stroke.
• 
  (L2)−(C)(sin (−α))=A  (4)
• where length “L2” is the length of pivotingdrive arm156 taken frompivot post156ato drivingpost156c,distance “C” is the distance betweencoupling pin158cofdistal linkage member158 and drivingpost156cof pivotingdrive arm156 taken along the longitudinal axis “X1,” and distance “A” is the distance between fixedrod154aofproximal linkage member154 andpivot pin156aof pivotingdrive arm156 taken along a reference axis orthogonal to the longitudinal axis “X1,” as shown inFIG. 42B.
• With continued reference toFIG. 32-38, during the further squeezing ofhandles106, withtab192aremoved fromcounter mechanism190, asdrive channel140 is advanced distally,nub140ethereof engages contact194aofprocessor194 thereby completing a circuit and causingprocessor194 to perform a function, as described above.
• Referring now toFIGS. 39-44,clip applier100 is illustrated during a final squeezing ofhandles106. In this condition,drive channel140 is at a distal position,pusher bar160 is at a distal position,wedge plate180 is at a proximal position, biasingmember146 is stretched, andpawl142 is located proximal of rack140d.
• Additionally, as seen inFIG. 43, withdistal end180aofwedge plate180 removed from betweenjaws120, asdrive channel140 is moved further distally, a distal edge ofdrive channel140 and/or drivechannel strap143 engages against camming surfaces120bofjaws120 thus causingjaws120 to approximate toward one another and to form surgical clip “C1” interposed therebetween. Sincedrive channel strap143 is fixed to drivechannel140 and moves therewith, drivechannel strap143 functions to capdrive channel140 so as to maintainjaws120 withindrive channel140 during the approximation ofjaws120 and to maintainwedge plate180 withindrive channel140 during operation ofclip applier100.
• As seen inFIG. 44, surgical clip “C1” may be formed or crimped onto a vessel “V” or any other biological tissue.
• Drive channel140 is permitted to move distally relative topusher bar160 due to the translation ofbosses148bofindicator148 throughslot160dofpusher bar160.
• Also, asdrive channel140 is fully advanced distally, as seen inFIG. 41,rack member141 ofratchet mechanism144 is moved distally to a location beyond pawl142 such that theteeth141aofrack member141 are moved distally of the tooth ofpawl142 thereby disengagingrack member141 andpawl142 from one another. In this manner,drive channel140 is permitted or free to return to a home or proximal-most position.
• As seen inFIG. 42, asdrive channel140 is moved distally,resilient arm148aof audible/tactile indicator148 snaps over the distal end ofledge149 and comes into contact with a surface149aofledge149, thereby creating an audible sound and/or a tactile vibration. Such audible sound and/or tactile vibration coincide with the loading of surgical clip “C”.
• Referring now toFIGS. 45-52, during an opening or release ofhandles106, distal ends122aoflink members122 are caused to be moved proximally relative tohousing104. As distal ends122aoflink members122 are moved proximally,drive pin124 is caused to be moved proximally thereby transmitting proximal axial movement to drivechannel140 and, in turn,pusher bar160. The proximal movement ofdrive channel140 is facilitated by the constriction of biasingmembers146. Alternatively, the release ofhandles106 results in biasingmember146 withdrawingdrive channel140 in a proximal direction.
• Asdrive channel140 is moved proximally, the distal edge ofdrive channel140 and/or drivechannel strap143 disengages from against camming surfaces120bofjaws120 thus freeingjaws120 for separation from one another for reinsertion ofdistal end180aofwedge plate180 therebetween, and to receive another surgical clip “C” therebetween. In particular, asdrive channel140 is moved proximally, the transverse portion ofslot140gacts onfinger179cto causepivot arm179 to rotate and causefinger179bofpivot arm179 to urgewedge plate180 distally. Aswedge plate180 is moved in a distal direction, as seen inFIGS. 51 and 52,distal end180aofwedge plate180 is reinserted or reintroduced intojaws120, thereby spreadingjaws120 apart.
• As seen inFIGS. 48 and 49, aswedge plate180 is moved distally,proximal tab176 ofclip follower174 engages in awindow180bofwedge plate180 and is thus urged distally a given distance. Asclip follower174 is urged distally, stack of clips “C” is also urged distally. As seen inFIG. 50, whenwedge plate180 reaches a distal-most position,clip channel170 abuts, engages, urges or otherwise cams againstproximal portion175bofdistal tab175 untilweb180fofwedge plate180 rests substantially beneathdistal portion175aofdistal tab175. In so doing,proximal portion175bofdistal tab175 is moved to extend into an incrementally moredistal window172 ofclip channel170.
• As seen inFIGS. 50 and 51, asclip follower174 is urged forward, moving the stack of clips “C” forward, a distal-most clip “C1” moves distal ofpusher160cby camming beneathpusher160cofpusher bar160 until distal-most clip “C1” is caught bytangs171 ofclip applier170.
• Turning momentarily toFIG. 47, asdrive channel140 is moved in a proximal direction,arm148aof audible/tactile indicator148 snaps back overledge149 and re-sets itself for the next firing stroke or squeeze ofhandles106.
• Asdrive channel140 is moved further in a proximal direction,drive channel140 effectuates proximal movement of pivotingdrive arm156, which, in turn, reverses the movement of the motion multiplier system.
• As seen inFIGS. 45-51, whilehandles106 are released and drivingchannel140 is moved in a proximal direction via biasing member146 (as shown inFIG. 39),coupling pin156aof pivotingdrive arm156 moves in a proximal direction such that angle “β,” between pivotingdrive arm156 and longitudinal axis “X2” ofdrive channel140, continuously decreases asdrive channel140 also moves in the proximal direction. In this manner, drivingpost158cofdistal linkage member158 starts to move in a distal direction, such that,pusher bar160 andstabilizer162 via slidingpost158cdistally move back to the “fully extended” position. At substantially the same time, as drivingpost158cofdistal linkage member158 starts to move in a distal direction, angle “−α” ofproximal linkage member154, positioned on the second side of longitudinal axis “X1,” increases from about −60° to about 0°. Asdrive channel140 further moves in the proximal direction,proximal linkage member154 pivots from the second side to the first side of longitudinal axis “X1,” such that, in the “fully extended” position, proximal anddistal linkage members154 and158 are again pivotally located in alignment with each other, such that angle “α” is about 0°. In other words, proximal anddistal linkage member154 and158 are between the first side and the second side of longitudinal axis “X1.”
• In this configuration, as driving channel is140 further continues to move in the proximal direction,pusher bar160 is moved proximally withdrive channel140, as described above, until pivotingdrive aim156 has reached a position, such that angle “β,” between pivotingdrive arm156 and longitudinal axis “X2” ofdrive channel140, is about 45°. In this manner,proximal linkage member154 moves to the first side, such that angle “α” starts to increase from about 0° to about 60°.
• Subsequently, asdrive channel140 is moved proximally, the reversingmotion multiplier system155 moves from the “fully extended” position to the “home” position. More particularly,drive channel140 advances in a proximal direction, which, in turn, causes pivotingdrive arm156 to move in a proximal direction. That is, pivotingdrive arm156 pivots and drivesproximal linkage member154 in a direction such that angle “β,” between pivotingdrive arm156 and longitudinal axis “X2” ofdrive channel140, decreases to about 22° to about 45°. In this manner, proximal linkage member causes distal linkage member to pivotally slide proximally alongslot162bofstabilizer162 andproximal window160dofpusher bar160. In this configuration,distal linkage member158 drives pusher bar160 in a proximal direction.
• Whendrive channel140 andpusher bar160 are located at the distal-most position, slidingpost156cof pivotingdrive arm156 is located at a distal-most position and secondresilient finger148bofindicator148 is disposed proximal ofedge149. Also, ashandles106 ofclip applier100 are released, withwedge plate180 located at a distal-most position,distal end180athereof is interposed betweenjaws120. Additionally, asdrive channel140 is moved in a proximal direction,nub140ethereof disengages contact194aofprocessor194.
• Turning now toFIG. 52, a distal end ofclip applier100 is illustrated following a complete stroke or squeezing ofhandles106 and after a final clip has been expelled therefrom. Following firing of the last clip, as seen inFIG. 52,proximal tab176 of clip follower is disposed within a distal-most aperture or window ofapertures180bofwedge plate180. In this manner, aswedge plate180 is moved distally following a firing of a clip, in the manner described above,clip follower174 is also moved distally. Accordingly; asclip follower174 is moved distally,distal tab175 thereof is moved distal of a distal-most window ofwindows172 ofclip carrier170. In this manner,proximal portion175bofdistal tab175 engages against an inner surface of a top wall ofclip carrier170 and is cammed or urged downwardly.
• Asproximal portion175bofdistal tab175 is cammed or urged downwardly,distal portion175aofdistal tab175 engages against an upper surface oftab178aoflockout178 and cams or urgestab178aoflockout178 downwardly, across a path ofstrap143, supported ondrive channel140, and intodistal window180cofwedge plate180. In this manner, ifdrive channel140 is advanced distally, in the manner described above,strap143 will abut againsttab178aoflockout178 and prevent or blockstrap143 and, in turn,drive channel140 from moving distally. At this stage,pawl142 is located in a dwell, distal of rack140d,and handles106 are arranged in a fully opened position and are thus not capable of being opened any further. In this configuration, clip applier is locked out and can no longer be used.
• Depending on the size of the surgical clip, the size of components ofclip applier100 will have to be scaled accordingly. The majority of the components of the various sized clip appliers will be substantially identical to one another. Components size relating to the width of the clips, such as thejaws120 and thewedge plate180, or components size relating to the length of the clip, such as thepusher bar160 and thepivot arm179, are adjusted accordingly. In this manner, each clip applier, of varying size, will be assembled in substantially the same manner and the inner mechanism thereof will operate in substantially the same manner.
• For example,clip applier100 may be provided in a relatively small, medium and large scale, wherein each of the sizes of clip appliers stores and fires a relatively small, medium or large surgical clip. Based on the relative dimensions of the surgical clips, the corresponding clip appliers, and their corresponding components, must be scaled appropriately. However, in accordance with the present disclosure, each of the various sized clip appliers comprise the same component and may be assembled in the same sequence as one another. In this manner, a technician assembling the clip appliers will only have to learn the sequence and/or steps required for the assembly of one of the sizes of clip appliers and, in turn, be able to assemble the other sizes of clip appliers equally, without having to learn a new sequence or step of assembly.
• Accordingly, the assembly method and/or steps for a relatively small, medium or large clip applier are substantially identical to one another.
• Many other remaining components or parts are identical or have minor variations in feature size or scale. However, if desired, the shapes of the following parts may be modified in order to achieve the same result, namely, the length ofproximal linkage member154, the length of pivotingdrive arm156, and/or the length ofdistal linkage member158.
• It is contemplated that varying the starting angle of angle “α,” for example, at about 45° versus at about 60°, is more effective, such that the angle difference creates a smoother starting action for the working stroke ofclip applier100. However, when starting angle “α” is about 45°, more area is taken up withinhousing104 ofclip applier100 due to longer proximal anddistal linkage members154 and158 than when the starting angle “α” is about 60°. All parameters of themotion multiplier system155 can and should be individually designed for any configuration need in the specific device in which the motion multiplier system is considered to be implemented within.
• It should be understood that the foregoing description is only illustrative of the present disclosure. Various alternatives and modifications can be devised by those skilled in the art without departing from the disclosure. Accordingly, the present disclosure is intended to embrace all such alternatives, modifications and variances. The embodiments described with reference to the attached drawing figures are presented only to demonstrate certain examples of the disclosure. Other elements, steps, methods and techniques that are insubstantially different from those described above and/or in the appended claims are also intended to be within the scope of the disclosure.

Claims (19)

1. A surgical clip applier for applying surgical clips to body tissue, the surgical clip applier comprising:

a housing;

at least one handle pivotably connected to the housing;

a channel assembly extending distally from the housing;

a clip carrier disposed within the channel assembly and defining a channel and a plurality of windows therein;

a plurality of clips slidably disposed within the channel of the clip carrier;

a drive channel reciprocally disposed within at least one of the housing and the channel assembly, the drive channel having a first end operatively connected to the at least one handle and a second end operatively connected to a distal end of the channel assembly;

a wedge plate reciprocally disposed within the channel assembly, the wedge plate being operatively connected to the at least one handle and including a plurality of apertures formed along a length thereof;

a pusher bar reciprocally positioned within the housing and the channel assembly, the pusher bar having a proximal end operatively connected to at least one handle and a distal end defining a pusher, wherein the distal end of the pusher bar is configured for engagement with a distal-most clip of the plurality of clips; and

a motion multiplier system having a plurality of linkage members configured to distally move the pusher bar by an incremental amount upon an initial actuation of the handles, and configured to proximally move the pusher bar and the wedge plate subsequent to the initial actuation of the handles.

2. The clip applier according toclaim 1, wherein the plurality of linkages of the motion multiplier system includes:

a proximal linkage member pivotally supported in the housing and operatively connected to the drive channel;

a pivoting drive arm interconnecting the drive channel and the proximal linkage member; and

a distal linkage member interconnecting the proximal linkage member the pusher bar;

wherein a distal translation of the drive channel causes the proximal linkage member to pivotally rotate via the pivoting drive arm, such that the proximal linkage member causes a first end of the distal linkage member to pivotally rotate in a first direction and a second end to slidably move the pusher bar in a distal direction.

3. The clip applier according toclaim 2, wherein a further distal translation of the drive channel cause the proximal linkage member to pivotally rotate via the pivoting drive arm, such that the proximal linkage member causes the first end of the distal linkage member to pivotally rotate in a second direction and the second end to slidably move the pusher bar in a proximal direction.

4. The clip applier according toclaim 1, wherein the plurality of linkages of the motion multiplier system includes:

a proximal linkage member pivotally supported in the housing and operatively connected to the drive channel;

a pivoting drive arm interconnecting the drive channel and the proximal linkage member; and

a distal linkage member interconnecting the proximal linkage member the pusher bar;

wherein a distal translation of the drive channel causes a pivotal rotation of the proximal linkage member via the pivoting drive arm, wherein the pivotal rotation of the proximal linkage member causes a pivotal rotation of the distal linkage member, and wherein the pivotal rotation of the distal linkage member causes a distal translation of the pusher bar.

5. The clip applier according toclaim 4, wherein a further distal translation of the drive channel causes a further pivotal rotation of the proximal linkage member via the pivoting drive arm, wherein the further pivotal rotation of the proximal linkage member causes a further pivotal rotation of the distal linkage member, and wherein the further pivotal rotation of the distal linkage member causes a proximal translation of the pusher bar.

6. The clip applier according toclaim 4, wherein when the proximal linkage member, the distal linkage member, the pivoting drive arm, the drive channel and the pusher bar are in a first position, the proximal linkage member and the distal linkage member define a first angle, wherein proximal translation of the drive channel causes the proximal linkage member and the distal linkage member, via the pivoting drive arm, to pivotally rotate thereby increasing the first angle to a second angle of about 180 degrees such that the proximal linkage member and the distal linkage member are linear to each other, such that the proximal linkage member, the distal linkage member, the pivoting drive arm, the drive channel and the pusher bar are in a second position.

7. The clip applier according toclaim 6, wherein when the proximal linkage member, the distal linkage member, the pivoting drive arm, the drive channel and the pusher bar are in the second position, further proximal translation of the drive channel causes the proximal linkage member and the distal linkage member, via the pivoting drive arm, to pivotally rotate thereby decreasing the second angle of about 180 degrees to a third angle, such that the distal linkage member, the pivoting drive arm, and the drive channel are in a third position, while the pusher bar is in the first position.

8. The clip applier according toclaim 4, wherein the rotation of the proximal linkage member via the pivoting drive arm causes the proximal linkage member and the distal linkage member to be linear to each other and along a longitudinal axis defined by a reference axis between the proximal end of the proximal linkage member and the distal end of the distal linkage member, such that the distal linkage member causes a distal translation of the pusher bar.

9. The clip applier according toclaim 8, wherein further rotation of the proximal linkage member via the pivoting drive arm causes the proximal member and the distal linkage member to be angularly offset from each other, such that the distal linkage member causes a proximal translation of the pusher bar.

10. The clip applier according toclaim 4, wherein a longitudinal axis, defined by a reference axis between the proximal end of the proximal linkage member and the distal end of the distal linkage member, and the proximal linkage member define a first acute angle on a first side of the longitudinal axis, and the pusher bar is in a proximal position, wherein distal translation of the drive channel causes the proximal linkage member and the distal linkage member to pivot such that the first acute angle on the first side of the longitudinal axis increases until the proximal linkage member and the distal linkage member are linear to each other and the pusher bar has been distally translated via the distal linkage member to a distal position.

11. The clip applier according toclaim 10, wherein further distal translation of the drive channel causes the proximal linkage member and the distal linkage member to pivot from the side of the longitudinal axis to a second side of the longitudinal axis such that the proximal linkage member and the longitudinal axis define a second acute angle and the pusher bar has been proximally translated via the distal linkage member to a proximal position.

12. The clip applier according toclaim 1, wherein the clip follower is configured to engage the wedge plate and move distally upon distal translation of the wedge plate, and is configured to engage the clip carrier and stop proximal movement thereof upon proximal translation of the wedge plate.

13. The clip applier according toclaim 1, further comprising a jaw assembly including a pair of jaws extending from an end of the channel assembly, opposite the housing, the jaw assembly adapted to accommodate a clip of the plurality of clips therein and being operable to effect formation of the clip in response to movement of the handles.

14. The clip applier according toclaim 13, wherein the pusher bar is movable towards the jaws as the handles are approximated in a first direction by an initial amount in order to move a distal-most clip between the jaws, and the pusher bar being configured and adapted to move towards the housing as the handles are approximated an additional amount in the first direction to move the pusher behind a distal-most clip in the plurality of clips.

15. The clip applier according toclaim 14, wherein the drive channel is configured and dimensioned to at least partially surround the jaws and the wedge plate, wherein the drive channel includes a strap extending across a distal end thereof for maintaining the jaws and the wedge plate within the drive channel.

16. The clip applier according toclaim 14, wherein the drive channel is moved towards the jaw assembly as the at least one handle is moved actuated in a first direction to move the second end of the drive channel against the jaws to close the jaws, the drive channel being moved away from the jaws as the at least one handle is moved a second amount to move the second end of the drive channel away from the jaws to allow the jaws to open.

17. The clip applier according toclaim 16, further comprising a motion reversing mechanism operatively connected to the wedge plate and the drive channel, wherein rotation of the motion reversing mechanism, during distal movement of the drive channel, results in proximal movement of the wedge plate.

18. The clip applier according toclaim 1, further comprising:

a clip follower slidably disposed within the channel of the clip carrier and disposed proximally of the plurality of clips, the clip follower being configured and adapted for selective engagement with the windows of the clip carrier and the apertures of the wedge plate, wherein the clip follower is configured and adapted to urge the plurality of clips, in a distal direction relative to the clip carrier, upon reciprocal movement of the wedge plate; and

19. The clip applier according toclaim 1, further comprising:

a motion reversing mechanism operatively connected to the drive channel and the wedge plate and selectively engageable with the pusher bar, wherein rotation of the motion reversing mechanism, during the distal translation of the drive channel, results in proximal movement of the wedge plate and the pusher bar.

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